QUADROX-i Adult/Small Adult Oxygenators; QUADROX-iD Adult Oxygenators— 510(k) K150267
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K150267 for QUADROX-i Adult/Small Adult Oxygenators; QUADROX-iD Adult Oxygenators, Substantially Equivalent on 2015-05-07. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.
Clearance details
- Device name as filed
- QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rastatt De-Bw, DE
Recent devices under product code DTZ
view all- K253838 — Lifemotion Disposable Membrane Oxygenator
- K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more
- K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more
- K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
- K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
More clearances from Maquet Cardiopulmonary, AG
view all- K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
- K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
- K133598 — CARDIOHELP SYSTEM
- K133265 — QUADROX-IR ADULT AND SMALL ADULT
- K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K150267
K-number listed on FDA's recall record- Z-1636-2023 — BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
- Z-1371-2016 — QUADROX-i oxygenators Custom tubing packs for the oxygenator
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150267.
Data sourced from openFDA. This site is unofficial and independent of the FDA.